Ketoprofen
Actron, Nexcede, Orudis, Oruvail (ketoprofen) is a small molecule pharmaceutical. Ketoprofen was first approved as Orudis on 1986-01-09. It is used to treat dysmenorrhea, osteoarthritis, and rheumatoid arthritis in the USA. The pharmaceutical is active against prostaglandin G/H synthase 2 and prostaglandin G/H synthase 1. In addition, it is known to target sodium-coupled monocarboxylate transporter 1.
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Trade Name
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EMA
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Drug Products
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EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ketoprofen
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ACTRON | Bayer | N-020499 DISCN | 1995-10-06 | 1 products |
| NEXCEDE | Novartis | N-022470 DISCN | 2009-11-25 | 1 products |
| ORUDIS | Wyeth | N-018754 DISCN | 1986-01-09 | 3 products, RLD |
| ORUDIS KT | Wyeth | N-020429 DISCN | 1995-10-06 | 1 products, RLD |
| ORUVAIL | WYETH PHARMS INC | N-019816 DISCN | 1993-09-24 | 3 products, RLD |
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Labels
FDA
EMA
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| dysmenorrhea | HP_0100607 | D004412 | N94.6 |
| osteoarthritis | EFO_0002506 | D010003 | M15-M19 |
| rheumatoid arthritis | EFO_0000685 | D001172 | M06.9 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
M: Musculo-skeletal system drugs
— M01: Antiinflammatory and antirheumatic products
— M01A: Antiinflammatory and antirheumatic products, non-steroids
— M01AE: Propionic acid derivatives, antiinflammatory and antirheumatic products
— M01AE03: Ketoprofen
— M01AE53: Ketoprofen, combinations
— M02: Topical products for joint and muscular pain
— M02A: Topical products for joint and muscular pain
— M02AA: Antiinflammatory preparations, non-steroids for topical use
— M02AA10: Ketoprofen
HCPCS
No data
Clinical
Clinical Trials
85 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pain | D010146 | EFO_0003843 | R52 | — | 1 | 6 | 2 | — | 9 |
| Postoperative pain | D010149 | G89.18 | — | 1 | 1 | 3 | 1 | 6 | |
| Cesarean section | D002585 | — | — | — | 4 | — | 4 | ||
| Ankle injuries | D016512 | S93.4 | — | — | 2 | 2 | — | 4 | |
| Low back pain | D017116 | HP_0003419 | M54.5 | — | — | 1 | 2 | — | 3 |
| Lymphedema | D008209 | Q82.0 | — | — | — | 1 | 2 | 3 | |
| Neuralgia | D009437 | EFO_0009430 | — | — | — | 2 | — | 2 | |
| Pain management | D059408 | — | — | — | 1 | — | 1 | ||
| Recovery of function | D020127 | — | — | — | 1 | — | 1 | ||
| Renal colic | D056844 | EFO_1001412 | N23 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | 4 | 4 | — | — | 8 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | — | 5 | — | — | 5 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | — | — | 4 | — | 1 | 5 |
| Musculoskeletal pain | D059352 | 1 | — | 3 | — | — | 4 | ||
| Sprains and strains | D013180 | — | — | 4 | — | — | 4 | ||
| Tendinopathy | D052256 | EFO_1001434 | M77.9 | — | 1 | 3 | — | — | 4 |
| Bursitis | D002062 | EFO_1000941 | M71.9 | — | — | 2 | — | — | 2 |
| Chronic periodontitis | D055113 | EFO_0006343 | K05.3 | — | 1 | 1 | — | — | 1 |
| Postoperative nausea and vomiting | D020250 | EFO_0004888 | — | — | 1 | — | — | 1 | |
| Cholecystectomy | D002763 | — | — | 1 | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 2 | — | — | — | 2 | 4 | ||
| Major depressive disorder | D003865 | EFO_0003761 | F22 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | C80 | — | — | — | — | 2 | 2 | |
| Post-dural puncture headache | D051299 | — | — | — | — | 1 | 1 | ||
| Induced abortion | D000028 | — | — | — | — | 1 | 1 | ||
| Ventricular dysfunction | D018754 | — | — | — | — | 1 | 1 | ||
| Atrial heart septal defects | D006344 | EFO_1000825 | Q21.1 | — | — | — | — | 1 | 1 |
| Pericardial effusion | D010490 | EFO_0007298 | I31.39 | — | — | — | — | 1 | 1 |
| Hiv | D006678 | O98.7 | — | — | — | — | 1 | 1 | |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 1 | 1 |
| Female infertility | D007247 | EFO_0008560 | N97 | — | — | — | — | 1 | 1 |
| Infantile diarrhea | D003968 | EFO_1001306 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | KETOPROFEN |
| INN | ketoprofen |
| Description | Ketoprofen is an oxo monocarboxylic acid that consists of propionic acid substituted by a 3-benzoylphenyl group at position 2. It has a role as a non-steroidal anti-inflammatory drug, an antipyretic, an EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor, an environmental contaminant, a xenobiotic and a drug allergen. It is a member of benzophenones and an oxo monocarboxylic acid. It is functionally related to a propionic acid. |
| Classification | Small molecule |
| Drug class | anti-inflammatory/analgesic agents (ibuprofen type) |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CC(C(=O)O)c1cccc(C(=O)c2ccccc2)c1 |
Identifiers
| PDB | — |
| CAS-ID | 22071-15-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL571 |
| ChEBI ID | 6128 |
| PubChem CID | 3825 |
| DrugBank | DB01009 |
| UNII ID | 90Y4QC304K (ChemIDplus, GSRS) |
Target
Agency Approved
PTGS2
PTGS2
PTGS1
PTGS1
Organism
Homo sapiens
Gene name
PTGS2
Gene synonyms
COX2
NCBI Gene ID
Protein name
prostaglandin G/H synthase 2
Protein synonyms
COX-2, cyclooxygenase 2, cyclooxygenase 2b, Cyclooxygenase-2, PGH synthase 2, PGHS-2, PHS II, Prostaglandin H2 synthase 2, Prostaglandin-endoperoxide synthase 2, prostaglandin-endoperoxide synthase 2 (prostaglandin G/H synthase and cyclooxygenase)
Uniprot ID
Mouse ortholog
Ptgs2 (19225)
prostaglandin G/H synthase 2 (Q543K3)
Alternate
SLC5A8
SLC5A8
Organism
Homo sapiens
Gene name
SLC5A8
Gene synonyms
AIT, SMCT, SMCT1
NCBI Gene ID
Protein name
sodium-coupled monocarboxylate transporter 1
Protein synonyms
Apical iodide transporter, Electrogenic sodium monocarboxylate cotransporter, Sodium iodide-related cotransporter, solute carrier family 5 (iodide transporter), member 8, solute carrier family 5 (sodium/monocarboxylate cotransporter), member 8, Solute carrier family 5 member 8
Uniprot ID
Mouse ortholog
Slc5a8 (216225)
sodium-coupled monocarboxylate transporter 1 (Q8VD01)
Variants
Clinical Variant
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Financial
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Trends
PubMed Central
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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7,939 adverse events reported
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